Pain Control Following Sinus Surgery | NCT03783702

Name	Class
Mayo Clinic	OTHER
Vanderbilt University Medical Center	OTHER
Albert Einstein College of Medicine	OTHER
University of British Columbia

Label	Type	Description	Intervention Names
Experimental group	Experimental	Patients in the experimental group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is ibuprofen (600mg tablet by mouth every 6 hours). Oxycodone (5mg tablet by mouth every 4 hours) will be the third-line medication to be used if acetaminophen and ibuprofen do not sufficiently control the pain.	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet Drug: Ibuprofen 600 Mg (milligram) Oral Tablet Drug: Acetaminophen 650 MG (milligram) Oral Tablet
Control group	Active Comparator	Patients in the control group will be asked to start with acetaminophen (650mg tablet by mouth every 6 hours) when they are in pain. If they still require additional analgesics, the second-line medication is oxycodone (5mg tablet by mouth every 4 hours).	Drug: OxyCODONE 5 Mg (milligram) Oral Tablet Drug: Acetaminophen 650 MG (milligram) Oral Tablet

Name	Type	Description	Arm Group Labels	Other Names
OxyCODONE 5 Mg (milligram) Oral Tablet	Drug	Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.	Control group

Measure	Description	Time Frame
Pain Severity	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.	Average pain score will be collected for preoperative visit (the day before surgery)
Pain Severity	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.	Average pain score was collected for postoperative day 1
Pain Severity	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.	Average pain score will be collected for postoperative day 2
Pain Severity	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.	Average pain score will be collected for postoperative day 3
Pain Severity	A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Measure	Description	Time Frame
Brief Pain Inventory (BPI) Score	The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain). Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Health Care		Stanford	California	94305	United States
NorthShore University Health System

PubMed Identifier	Type	Citation	Retractions
20058315	Background	Bhattacharyya N. Ambulatory sinus and nasal surgery in the United States: demographics and perioperative outcomes. Laryngoscope. 2010 Mar;120(3):635-8. doi: 10.1002/lary.20777.
29460670	Background	Schwartz MA, Naples JG, Kuo CL, Falcone TE. Opioid Prescribing Patterns among Otolaryngologists. Otolaryngol Head Neck Surg. 2018 May;158(5):854-859. doi: 10.1177/0194599818757959. Epub 2018 Feb 20.

ID	Title	Description
FG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 7, 2018

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for preoperative visit (the day before surgery)

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG00049 OG00151

Title

Denominators

Categories

Title	Measurements
	OG00012.4± 20.0 OG0018.5± 13.5

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score was collected for postoperative day 1

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for postoperative day 2

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for postoperative day 3

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for postoperative day 4

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for postoperative day 5

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for postoperative day 6

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Pain Severity

A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no pain" with a score of 0 to "worst imaginable pain," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Average pain score will be collected for postoperative day 7

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Primary

Medication Log

Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group.

Posted

Mean

Standard Deviation

Average number of medication doses/day

Postoperative day 1 to 7

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

BPI score will be collected at the preoperative visit

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 1

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 2

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 3

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 4

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 5

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 6

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Brief Pain Inventory (BPI) Score

The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its "least," "worst," "average," and "now." The score ranges from 0 to 10 (higher indicates more pain).

Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318.

Posted

Mean

Standard Deviation

units on a scale

Average BPI score will be collected for postoperative day 7

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected at the preoperative visit

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 1

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 2

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 3

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 4

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 5

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 6

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

Secondary

Severity of Epistaxis

A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from "no bleeding" with a score of 0 to "continuous bleeding," corresponding to a score of 100.

Posted

Mean

Standard Deviation

units on a scale

Epistaxis severity will be collected for postoperative day 7

ID	Title	Description
OG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
OG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics

Units	Counts
Participants	OG000

ID	Term
D012852	Sinusitis
D009293	Opioid-Related Disorders
D010038	Otorhinolaryngologic Diseases
D010149	Pain, Postoperative
D010146	Pain

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D010098	Oxycodone
D008274	Magnesium
D013607	Tablets
D007052	Ibuprofen
D000082	Acetaminophen

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light
D008670	Metals
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D000814	Aniline Compounds
D000588	Amines

ID	Title	Description
BG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
BG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: ibuprofen 600mg tablet by mouth every 6 hours if they still require additional analgesics rd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	0	49	0	49	0	49
EG001	Control Group	st line analgesic: acetaminophen 650mg tablet by mouth every 6 hours nd line analgesic: oxycodone 5mg tablet by mouth every 4 hours if they still require additional analgesics	0	51	0	51	0	51